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dc.contributor.authorGriesinger, F.
dc.contributor.authorKim, H. R.
dc.contributor.authorAhn, M. J.
dc.contributor.authorYang, J. C.
dc.contributor.authorHan, J. Y.
dc.contributor.authorHochmair, M.
dc.contributor.authorLee, K. H.
dc.contributor.authorDelmonte, A.
dc.contributor.authorCampelo, M. R. G.
dc.contributor.authorKim, D. W.
dc.contributor.authorFelip, E.
dc.contributor.authorCalifano, Raffaele
dc.contributor.authorSpira, A.
dc.contributor.authorGettinger, S.
dc.contributor.authorTiseo, M.
dc.contributor.authorLin, H.
dc.contributor.authorLiu, Y.
dc.contributor.authorZhang, P.
dc.contributor.authorPopat, S.
dc.contributor.authorCamidge, D. R.
dc.date.accessioned2020-11-16T07:49:09Z
dc.date.available2020-11-16T07:49:09Z
dc.date.issued2020en
dc.identifier.citationGriesinger F, Kim HR, Ahn MJ, Yang JC, Han JY, Hochmair M, et al. Brigatinib vs crizotinib in the phase 3 ALTA-1L trial: Updated results. Oncology Research and Treatment. 2020;43(SUPPL 4):142-en
dc.identifier.urihttp://hdl.handle.net/10541/623385
dc.description.abstractIntroduction: We report results of the second interim analysis from ALTA-1L (NCT02737501), planned at 75% of 198 expected events. Methods: Patients with anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI)-naive advanced ALK-positive non-small cell lung cancer (ALK+ NSCLC) were enrolled. One prior chemotherapy for advanced NSCLC and asymptomatic brain metastases were allowed. Patients were randomized 1:1 to brigatinib 180 mg qd with 7-day lead-in at 90 mg or crizotinib 250 mg BID. The primary endpoint was blinded independent review committee (BIRC)-assessed progression-free survival (PFS; RECIST v1.1). Secondary endpoints (by BIRC) included confirmed objective response rate (ORR) and intracranial ORR (iORR), as well as intracranial PFS (iPFS). Results: 275 patients were randomized (brigatinib/crizotinib, n=137/138); median age was 58/60 years. In total, 26%/27% received prior chemotherapy; 29%/30% had baseline brain metastases. As of 28 June 2019, median follow-up for brigatinib/crizotinib was 24.9/15.2 mo, with 150 PFS events. BIRC-assessed PFS HR was 0.49 (95% CI 0.35-0.68; log-rank P< 0.0001); median PFS (mPFS) was 24.0 mo (18.5-not estimable [NE]) for brigatinib vs 11.0 mo (9.2-12.9) for crizotinib. Investigator-assessed PFS HR was 0.43 (0.31-0.61; mPFS 29.4 vs 9.2 mo). Overall survival was immature (events: 33/37, brigatinib/crizotinib). Early benefit for brigatinib was observed in patients with baseline brain metastases; 6 mo PFS by BIRC was 89.0% for brigatinib and 47.5% for crizotinib. Independent of prior chemotherapy, the subgroup of patients with baseline brain metastases consistently benefited more than those without baseline brain metastases. Table shows additional efficacy data. Conclusions: Brigatinib showed superior PFS vs crizotinib in all patient subgroups with ALK TKI-naive ALK+ NSCLC. Based on these data, brigatinib has been approved by the EMA in 2020 for first-line therapy.en
dc.language.isoenen
dc.titleBrigatinib vs crizotinib in the phase 3 ALTA-1L trial: Updated resultsen
dc.typeMeetings and Proceedingsen
dc.contributor.departmentCarl von Ossietzky Univ Oldenburg, Pius Hosp Oldenburg, Oldenburg, Germanyen
dc.identifier.journalOncology Research and Treatmenten
dc.description.noteen]


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